Calculase Laser Fiber

GUDID B145110881

940 micrometer Calculase Laser Fiber

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable
Primary Device IDB145110881
NIH Device Record Key289b01bd-f6bb-40b1-b58d-dbf3dc0e4612
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalculase Laser Fiber
Version Model Number11086
Company DUNS024050887
Company NameOPTICAL INTEGRITY INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com

Device Dimensions

Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer
Device Size Text, specify0
Outer Diameter940 Micrometer

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB145110860 [Primary]
HIBCCB145110881 [Package]
Contains: B145110860
Package: box [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


[B145110881]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-08-03

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B14527750300U1C31300 micrometer Calculase Laser Fiber
B14527750272U1C31272 micrometer Calculase Laser Fiber
B14527750200U1C31200 micrometer Calculase Laser Fiber
B145110881940 micrometer Calculase Laser Fiber
B145110841550 micrometer Calculase Laser Fiber
B145110801365 micrometer Calculase Laser Fiber
B145110761300 micrometer Calculase Laser Fiber
B145110721272 micrometer Calculase Laser Fiber
B145110681200 micrometer Calculase Laser Fiber

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